BridgeMD
New treatment option for COVID-19
Official title Local Thermotherapy for Patients With Mild-to-moderate COVID-19
ClinicalTrials.gov ID: NCT04363541
What this study is testing
- What it's testing
- The etiological agent of the current pandemic is a (+)ssRNA virus. SARS-CoV-2 is infecting thousands of people in the world with a fatality rate that varies from 0.1 to 5% in affected countries, thereby causing enormous economic losses.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient with symptoms of COVID-19 (fever, headache, cough, sore throat, myalgias, arthralgias, shortness of breath, anosmia, fatigue, diarrhea...
- Mild COVID-19: With or without mild pneumonia. Peripheral oxygen arterial saturation (SaO2) greater than or equal to 94% (90% in Mexico City and...
- Moderate COVID-19: Patient with pneumonia and risk factors for disease progression; meeting all the following: Shortness of breath, peripheral oxygen...
- Patient with less than or equal to 5 days from symptom onset
- Participant understands the intervention and procedures and accepts randomization.
You likely can't join if
- Suspected or confirmed pregnancy at evaluation
- Severe decompensation of any of the patient's underlying diseases
- Previous diagnosis of COVID-19 with complete resolution of symptoms for at least 2 days.
- Patients meeting criteria for severe or critical COVID-19 at evaluation:
- Severe COVID-19 - Patient with ≥1 of the following: tachypnea (≥30 breaths per minute), peripheral oxygen arterial saturation (SaO2) less than or...
- Critical COVID-19 - Patient with ARDS, shock, multiorgan failure, or any other condition requiring admission to an intensive care unit. Elimination...
See the full eligibility criteria
- Patient with symptoms of COVID-19 (fever, headache, cough, sore throat, myalgias, arthralgias, shortness of breath, anosmia, fatigue, diarrhea, vomit, or conjunctivitis) meeting criteria for mild or moderate COVID-19...
- Mild COVID-19: With or without mild pneumonia. Peripheral oxygen arterial saturation (SaO2) greater than or equal to 94% (90% in Mexico City and Guadalajara) at room air. Does not meet criteria of moderate, severe, or...
- Moderate COVID-19: Patient with pneumonia and risk factors for disease progression; meeting all the following: Shortness of breath, peripheral oxygen arterial saturation (SaO2) greater than or equal to 94% (90% in...
- Patient with less than or equal to 5 days from symptom onset
- Participant understands the intervention and procedures and accepts randomization.
- Suspected or confirmed pregnancy at evaluation
- Severe decompensation of any of the patient's underlying diseases
- Previous diagnosis of COVID-19 with complete resolution of symptoms for at least 2 days.
- Patients meeting criteria for severe or critical COVID-19 at evaluation:
- Severe COVID-19 - Patient with ≥1 of the following: tachypnea (≥30 breaths per minute), peripheral oxygen arterial saturation (SaO2) less than or equal to 93% (89% in Mexico City and Guadalajara) with a maximum 3 L/min...
- Critical COVID-19 - Patient with ARDS, shock, multiorgan failure, or any other condition requiring admission to an intensive care unit. Elimination Criteria:
- Participant retires consent to participate in the study
- Patient requiring ≥4 L/min of supplementary oxygen in the 24 hours of hospitalization (in the case that randomization occurred in the first 24 hours of hospitalization)
- Two negative tests against SARS-CoV-2 (a sequential diagnostic strategy will be implemented to reduce losses due to false negative tests).
- Patient that do not tolerate thermotherapy and requests to stop receiving the intervention.
- Transfer to another medical unit in the first 5 days of inclusion in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Guadalajara, Jalisco, Mexico
- Villahermosa, Tabasco, Mexico
- Mexico City, Mexico
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guadalajara, Jalisco, Mexico; Villahermosa, Tabasco, Mexico; Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.